Clinical trial · Interventional
Gene Expression Profiling in Patients With Invasive Bladder Cancer Receiving Methotrexate, Vinblastine, Doxorubicin, and Cisplatin
Phase II Clinical Trial Concerning Gene Expression Profiling to Predict the Chemosensitivity of Invasive Bladder Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawn due to lack of enrollment.
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as methotrexate, vinblastine, doxorubicin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Evaluating blood or tissue samples from patients with cancer may help doctors learn more about changes that occur in DNA, identify biomarkers related to cancer, and predict how well patients will respond to combination chemotherapy. PURPOSE: This phase II trial is studying gene expression profiling to see how well it works in predicting response to treatment in patients with invasive bladder cancer receiving methotrexate, vinblastine, doxorubicin, and cisplatin.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| gene expression profiling | Genetic | — | UNRESOLVED |
| methotrexate | Drug | Methotrexate | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| vinblastine | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Detection of genes associated with sensitivity to the chemotherapy in tumor size reduction of original bladder tumor
Secondary outcomes (3)
- measure
- Safety
- measure
- Overall survival rate
- measure
- Size reduction of metastatic lesion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of invasive bladder cancer * Must be confirmed by chest and abdominal CT scan OR pelvic MRI scan and transurethral biopsy (with definitive muscle invasion \> T2) within 4 weeks prior to registration PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * WBC ≥ 3,000/mm\^3 * Neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Total bilirubin ≤ 1.5 mg/dL * Serum creatinine ≤ 1.5 mg/dL * AST and ALT ≤ 2.5 x upper limit of normal * Not pregnant * No liver cirrhosis * No ischemic cardiovascular disease or arrhythmia for which treatment is necessary * No cardiac infarction within the past 6 months * No interstitial pneumonia, pulmonary fibrosis, or any other diseases by which oxygen inhalation therapy is needed * No active cancerous lesion other than upper urinary tract tumor * No high fever or any other infectious symptom * No uncontrolled hypertension or diabetes mellitus PRIOR CONCURRENT THERAPY: * No prior systemic chemotherapy
References
Publications (0)
Data not yet available